Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus

NCT00526513 | Completed Phase 4

• 1 other identifier: APIDR_L_01913
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives: To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG \& PPBG) from baseline to the end of the study. Secondary Objectives: To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Glycosylated Haemoglobin (HbA1c)

  At 3 months after the treatment start

• Glycosylated Haemoglobin (HbA1c)

  At 6 months after the treatment start

Secondary Outcomes (3)

• Control of Fasting Blood Glucose (FBG)

  At 3 months after the treatment start

• Control of Post-Prandial Glycemia (PPBG)

  At 3 months after the treatment start

• Control of Post-Prandial Glycemia (PPBG)

  At 6 months after the treatment start

Interventions

Insulin Glulisine DRUG

subcutaneous injection of insulin glulisine at meal, 1 to 3 injections a day based on the condition of the patient in addition to a basal SC insulin injection at bedtime

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 1 or type 2 diabetes mellitus previously treated for 6 months with prandial insulin + Basal insulin or Premix (Type I) or by either a basal insulin + OAD or basal + RHI/other short acting analogue insulin or Premix (Type II) with HbA1c \>7%.
• Adequate hepatic and renal functions
• Ability and willingness of a tight antidiabetic therapy and to perform blood glucose self-monitoring and especially blood glucose profiles, using a blood glucometer at home.

You may not qualify if:

• Pregnant or lactating women or women of childbearing potential not using adequate contraception.
• Patients with hypersensitivity to insulin glulisine or to any of the excipients.
• History of diabetic ketoacidosis.
• Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
• Alcohol abuse or drug abuse.
• Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or psychiatric illness, other serious illnesses, uncontrolled medical conditions or active infections making implementation of the protocol difficult.
• Medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature and scope of the study. Mental retardation or language barrier such that the patient is unable to give informed consent.
• Participation in an investigational trial within 30 days of study entry.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mosaad I Morsi, MBBCH, MSC

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 13, 2010

Record last verified: 2010-09

Locations

EG (1)